Public health
Conditions
Interventions
C-E Group:DAY 1: smoke 1 cigarette in 5 min, DAY 3: E-cigarette ad lib for 5 min
E-C Group:DAY 1: E-cigarette ad lib for 5 min, DAY 3: smoke 1 cigarette in 5 min
Sponsors
Dongguan Kanghua Hospital Phase I Clinical Trial Research Center
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Male or female aged 18 to 45 (including threshold); 2.Body weight: Male subjects should not be less than 50 kg, female subjects should not be less than 45 kg, body mass index [BMI= weight (kg)/height 2 (m2)] within the range of 19.0-26.0 kg/m2 (including boundary value); 3.Physical examination, vital signs monitoring, ELECTROcardiogram examination, pregnancy test (only for female subjects), laboratory examination (including blood routine examination, urine ten items, blood biochemistry), drug five items screening and alcohol breath test, eight qualitative tests before blood transfusion and other examinations (including: Hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, HIV antibody) with normal results or abnormal results judged by researchers and no clinical significance; 4.Smoking cigarettes only or smoking cigarettes + e-cigarettes at the same time before screening; 5.Urine cotinine test was positive during screening and inclusion; 6.Carbon monoxide content in expiratory breath >= 10 PPM at screening time; 7.Screening subjects self-reported at least 10 cigarettes per day on average; 8.Subjects fully understand the purpose, nature, methods and possible adverse reactions of the study, voluntarily act as subjects, and sign informed consent prior to the start of any study procedure; 9.Subjects can communicate well with researchers and complete the study according to the study regulations.
Exclusion criteria
Exclusion criteria: 1.People with allergies (such as those who are known to be allergic to two or more substances) or to any components in e-cigarettes or cigarette oil (such as benzoic acid, propylene glycol, glycerin, nicotine, etc.); 2.Smoking cessation treatment in any form, including but not limited to nicotine replacement therapy, vachnicline, wellbutrin, etc.; 3.Those who have received smoking cessation treatment within the past 3 months; 4.Pregnant or lactating women, and all fertile male subjects (or their partners) or female subjects who have pregnancy plans from the screening period to 6 months after the end of the study, are unwilling to use adequate and effective contraceptive methods (see Appendix 1 for specific contraceptive methods), and have sperm donation or egg donation plans; 5.Suffering from mental illness and drug addiction; 6.Currently or has a history of alcohol abuse, has a history of substance abuse in the last 6 months, or is dependent on illegal drugs; 7.Respiratory infection, or use of any anti-inflammatory drugs, including but not limited to glucocorticoids; 8.Have a history of chronic diseases, such as lung or heart disease, diabetes, cancer, etc.; 9.Patients with serious diseases of the heart, lung, brain and blood system, including but not limited to 3 months after acute myocardial infarction, severe arrhythmia, unstable angina pectoris, poorly controlled hypertension, chronic obstructive pulmonary disease and severe asthma; 10.Regular use of tobacco products other than cigarettes; 11.Other conditions that cannot meet the study requirements as judged by the researcher, such as recent myocardial infarction, unstable or worsening angina pectoris, severe arrhythmia, recent stroke, etc.; 12.In any life-threatening situation, life expectancy is less than one year; 13.People with special dietary requirements, who cannot accept the uniform diet (such as intolerance to standard food) or who have dysphagia; 14.Poor vascular puncture conditions, intolerance to venipuncture or history of needle sickness 15.Participants in or currently participating in other clinical trials within 3 months prior to the use of the study product (pharmaceutical clinical trials are defined as the use of investigational drugs); 16.The researcher considers it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pulmonary ventilation function;DLCO;FeNO;airway resistance test;echocardiography;Blood pressure;pulse;heart rate;oxyhemoglobin saturation;blood routine examination;blood lipid;hs-CRP;HCY;coagulation function;IL-6; | — |
Countries
China
Contacts
Public ContactZhong Guoping
Dongguan Kanghua Hospital
Outcome results
None listed